Spine stabilization device
Abstract
This record has no abstract on file.
Term
3.4 yearsto projected expiry
Projected expiry 24 February 2030, counted from filing; an application has no term until it is granted.
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10 claims: 7 independent, 3 dependent
- 1Zastrzeżenia patentowe 1. Urządzenie do stabilizacji kręgosłupa, zawierające:- rozpórkę międzytrzonową (3) ukształtowaną do wprowadzania między trzon kręgowy (1) górnego kręgu i trzon kręgowy (2) dolnego kręgu i zawierającą górną powierzchnię (11) skierowaną w kierunku dolnej płytki końcowej trzonu kręgowego górnego kręgu i dolną powierzchnię skierowaną w kierunku górnej płytki końcowej trzonu kręgowego dolnego kręgu;- przekładkę międzykręgową zawierającą co najmniej jedno kanałowe wgłębienie (123) sięgające końca w powierzchni górnej oraz co najmniej jedno kanałowe wgłębienie (123) sięgające końca w powierzchni dolnej, oraz zawierająca w obszarze tych wgłębień strukturę (124) która obejmuje podcięcie, poprzez co jest odpowiednia do tworzenia pozytywnego połączenia kształtowego razem z urządzeniem kotwiącym (121), - dla każdego kanałowego wgłębienia urządzenie kotwiące (121), przy czym urządzenia kotwiące zawierające koniec proksymalny oraz koniec dystalny, pierwszą część mocująca (127), drugą część mocująca (127) oraz część mostkową (128) pomiędzy pierwszą i drugą częściami mocującymi znamienne tym, że przekładka międzykręgowa (3) zawiera otwór przelotowy (12) umieszczony podłużnie względem osi kręgosłupa.
- 2Urządzenie do stabilizacji kręgosłupa według zastrz. 1, w którym koniec w powierzchni górnej oraz koniec w powierzchni dolnej są końcami przednimi.
- 3Urządzenie do stabilizacji kręgosłupa według zastrz. 1 albo 2, w którym każda z pierwszych i drugich części mocujących (127) wystaje, na stronie dystalnej dalej niż część mostkowa (128).
- 4Urządzenie do stabilizacji kręgosłupa według dowolnego z zastrz. 1-3, w którym pierwsza część mocująca (127) zawiera materiał nadający się do upłynnienia, przy czym pierwsza część mocująca jest wyposażona do bycia kotwioną w tkance kostnej przez materiał nadający się do upłynnienia, który będący upłynniony, ma penetrować oraz krzepnąc ponownie w tkance kostnej.
- 5Urządzenie do stabilizacji kręgosłupa według zastrz. 4, w którym obydwie, pierwsza i druga części mocujące (127) zawierają materiał nadający się do upłynnienia, przy czym druga część mocująca jest wyposażona do bycia kotwioną w strukturze, do wytwarzania pozytywnego połączenia kształtowego, przez materiał nadający się do upłynnienia, który ma penetrować oraz krzepnąć ponownie w strukturze (124).
- 6Urządzenie do stabilizacji kręgosłupa według dowolnego z zastrz. 1-5, zawierający w sumie cztery urządzenia kotwiące (121) oraz odpowiednią ilość kanałowych wgłębień (123), dwa w powierzchni górnej oraz dwa w powierzchni dolnej.
- 7Urządzenie do stabilizacji kręgosłupa według któregokolwiek z zastrz. 1-6, w którym przekładka międzykręgowa (3) jest wykonana z PEEK.
- 8Urządzenie do stabilizacji kręgosłupa według któregokolwiek z zastrz. 1-7, w którym przekładka międzykręgowa (3) zawiera strukturę zatrzymującą.
- 9Urządzenie do stabilizacji kręgosłupa według któregokolwiek z zastrz. 1-8, w którym struktura (124) zawiera otwartą strukturę porowatą co najmniej w pobliżu kanałowych wgłębień (123).
- 10Urządzenie do stabilizacji kręgosłupa według któregokolwiek z zastrz. 1-8, w którym kanałowe wgłębienia (123) tworzą pojedyncze wgłębienie z podcięciem. SpineWelding AG, Szwajcaria Pełnomocnik:EP 2 992 860 B1 Z-15996/17 1/1
Independent claims10
62 paragraphs in 1 section, as filed
[0001] The invention relates to a device for stabilizing the spine, used in spine operations as a spacer in place of a degenerated or damaged intervertebral disc, between two adjacent vertebral bodies for permanent fusion of two vertebrae. The invention further relates to sets of devices for performing implantation of a spine stabilization device and methods of implanting a device.
BACKGROUND OF THE INVENTION [0002] In the state of the art, implant systems are known that serve as struts between adjacent vertebral bodies intended to fuse them and replace damaged or degenerated intervertebral discs:
US 7,077,864 describes an example of a vertebral cage that can be implanted from the anterior, posterior, anterolateral or lateral position. The cage is an example of vertebral interbody spacer and spine stabilizer. The cage is filled with bone graft material or bone growth activating material that activates vertebral fusion for long-term stability. Preferably, three bolts are used to secure the cage, one bolt protruding up or down at one angle, and the other two bolts being at an angle that will diverge in opposite directions. Preferably, the screws are to be inserted through the posterior wall of the cage and through the end plates of the hard matter of the compacted bone into the softer, more spongy part of the bone of the adjacent upper and lower vertebral bodies to immobilize the position of the cage relative to the vertebral bodies. In addition, care must be taken when screwing in the front wall of the strut or cage so that the screw heads do not protrude outside the front wall of the cage and that the screws cannot loosen to avoid damage to the main blood vessels that run along the front of the spine.
[0003] Similarly, US 7,232,464 teaches an implant of an intervertebral strut with a three-dimensional structure with several drilled holes intended to receive screws or other longitudinal fixation elements that can be rigidly connected to the intervertebral implant and are anchored in adjacent vertebral bodies, either through penetration or bottom, either the top or both end plates. The fixation means are typically guided at an angle of more than 25 °, preferably 35 ° -55 ° from the median plane. This arrangement of immobilizing means ensures that the end bone of the adjacent vertebral bodies is anchored to the essentially compact bone. Again, special measures are taken so that the fastening means do not loosen or protrude to avoid damage to the main blood vessels.
[0004] The attachment of these and other interstitial struts to the vertebral bodies depends on the penetration of the compact matter of the end-plate bone. Thus, accurate positioning and angular guidance of the bolts is critical. Passing fixation agents through the end plates may weaken the aggregate bone of the end plates, compromising the stability of the vertebral bodies. This can be problematic if bone quality is already lowered by degenerative osteoporosis or traumatic wounds, or if multiple attachment attempts are needed during the surgical procedure. Furthermore, during spinal surgery, access to the use of instruments is often limited, and it may be difficult to pass the fastening means to the vertebral bodies at such pronounced angles, required for passing the immobilization means through the anterior or lateral wall of the interbody spacer implant, through the vertebral end plates.
[0005] US 7,255,698 discloses a device for stabilizing the vertebral bodies, which devices include an inter-spinal fusion implant and spinal immobilization devices screw-mounted in the inter-spinal fusion implant, so as to prevent the device from loosening. Spine fixation devices have a length exceeding the distance between two adjacent vertebral bodies and are coupled to both vertebral bodies by means of bolts or ratchet mechanism structures.
[0006] Also in this system, knitting should be made to ensure that the screw heads do not protrude outside the front wall of the cage and that the screws cannot loosen, to avoid damage to the main blood vessels that run along the front of the spine. Another potential problem lies in the coupling of devices for immobilizing the spine and vertebral bodies. Particularly in the case of already weakened bone, the fastening is based mainly on the mechanical engagement between a screw or staple with ratchet structures on one side and a relatively thin layer of the anterior substance of the compacted bone on the other. Permanent mechanical wear can damage bone tissue near the protruding screw or clamp, and this can lead to loosening of the screw or clamp.
[0007] DE 103 23 363, US 2006/0178745, US 7,060,079 and US 2006/0136061 all disclose intervertebral disc implants that are intended to support and improve spinal mobility. The implants are attached to the intervertebral bodies with the help of elements that are pushed into the grooves along the cranial and caudal surfaces of the implants' end.
SUMMARY OF THE INVENTION [0008] The object of the invention is to overcome the disadvantages associated with prior art intervertebral implants.
[0009] This object is achieved by the invention as defined in the claims.
[0010] The upper and lower vertebrae may be adjacent vertebrae. Then, the interbody spacer can replace the intervertebral disc and can serve as an implant for fusion of the spine or it can serve as an intervertebral disc prosthesis, restoring the function of the intervertebral disc. The concepts of the invention are also suitable for multi-segment fusion, i.e. replacement of multiple intervertebral discs. Most embodiments of the invention present the advantages of low overall height, and this makes them particularly suitable for multi-segment fusion.
[0011] Alternatively, the vertebra may be at least partially removed together with adjacent intervertebral discs. Then, the interstitial strut replaces the vertebral body of the at least partially removed vertebra, as well as the removed intervertebral discs and the upper and lower vertebrae are not initially adjacent vertebrae, but adjacent vertebrae removed.
[0012] Also, the immobilizing device for the interbody spacer (or anchoring devices) may / may be the only (i) immobilizing device (s) or may be auxiliary immobilizing devices used in addition to other immobilizing devices, for example according to the prior art. Such other locking devices may be, for example, socket screws for insertion from the rear side.
[0013] In this text, the dorsal and abdominal directions are often referred to as the posterior and anterior directions, according to the convention applicable to humans; this does not preclude the use of the devices and methods described herein also for veterinary purposes; in this case, 'front' should generally be replaced by 'abdominal' and 'posterior' by 'dorsal'. The term "upper" is also used in this text. "Lower", "above", "below", "up", "down" and this does not preclude the use of devices and methods for segments of the spine that are not vertical in the normal position. Generally, "upper" and "above" etc. refers to more cranial positions, "below" or "lower" to more caudal positions.
[0014] The interbody spacer is a three-dimensional body with the upper surface facing - and for example in contact with - the lower vertebral end plate above and with the lower surface facing - and for example in contact with - the upper vertebral end plate under the spacer, and with a peripheral surface that may include anterior, posterior, and lateral walls in anterior, posterior and posterior spinal orientations. The upper and lower surfaces of the strut may be substantially parallel. In other embodiments, they are slightly tilted towards each other in such a way that the dorsal part of the peripheral surface is lower than the ventral part of the wall of the peripheral surface, and the strut forms a flat wedge imitating the anatomical form of the intervertebral disc (or vertebral body with intervertebral discs).
[0015] Although in most embodiments, especially for anterior, anterolateral or lateral implantation, the interbody spacer is in one part, in special cases it may also contain multiple parts, in particular for dorsal implantations.
[0016] The median plane of the implanted interbody spacer runs approximately (not including the optional small stenosis) parallel to the adjacent vertebral end plates above and below. In the context of this application, median plane orientation is sometimes referred to as "horizontal", while "vertical" always refers to an orientation substantially parallel to the longitudinal (cranio-caudal) extension of the spine in the area of the spine in which two vertebral bodies must undergo merger.
[0017] For example, the interbody spacer is made of plastic, such as PEEK (polyether ether ketone) or titanium, but other biocompatible materials containing other plastics, other metals and ceramics are also possible. In some embodiments, a hydroxyapatite (HA) surface coating is used, which improves the ability to integrate the bone interbody spacer and therefore supports long-term stability.
[0018] The interbody spacer may further be shaped to include further structural elements such as depressions, drilled holes, depressions, bulges and other three-dimensional structures that change the properties of the strut and / or which accommodate the respective structures of at least one fixation device or anchoring device. In addition, the interbody spacer material need not be homogeneous: it may consist of more than one material component and / or may contain filler materials such as stabilizing fibers, etc.
[0019] With respect to the anchoring devices, each of the first and second attachment parts may protrude from the distal side, further than the bridge part. The first and possibly the second fastening parts may contain material that liquefies by heat energy (e.g. frictional heat generated by mechanical oscillations or absorption heat generated by the absorption of electromagnetic radiation (preferably spectrum or infrared frequency range), such that the first attachment part is adapted for anchoring in bone tissue by e.g. mechanical oscillation or electromagnetic radiation and optionally the second attachment part is adapted to be anchored in the same way in structures.
[0020] The device according to the invention is an improvement over the device shown in Figs. 26-29 WO 2008/034 276. More specifically, the first and second attachment parts each act as an anchor anchored in bone tissue and in the intervertebral spacer. Anchoring of these two elements is carried out simultaneously by joint action, e.g. mechanical vibrations or electromagnetic radiation connected to the anchoring device, and pressure force pushing them in the distal direction (corresponding to the rear direction). Due to the sternum part, the anchoring device then creates a permanent connection between the bone tissue and the intervertebral spacer.
[0021] Preferably, all four anchoring devices are provided, two to the top surface and two to the bottom surface.
[0022] Mechanical vibrations or oscillations suitable for the method of implanting the device according to embodiments of the invention, which include liquefied polymer by means of friction heat generated by mechanical vibrations, preferably have a frequency between 2 and 200 kHz (even more preferably between 10 and 100 kHz, or between and 40 kHz) and vibration energy 0.2 to 40W, in particular 0.2 to 20W, or 10W to 35W for special applications (for example, if the clamp contains a tubular element and a thermoplastic element with anchoring material) per square millimeter of active surface. The vibrating element is e.g. designed in such a way that its contact face oscillates mainly in the direction of the element axis (longitudinal vibrations) and with an amplitude between 1 and 100 μιτι, preferably about 10 to 30 μm or about 20 to 40 μm in applications with a tubular element . Rotational or radial oscillations are also possible.
[0023] In particular embodiments of the spine stabilization device, it is also possible to use, instead of mechanical vibrations, a rotational movement to generate said heat of friction needed to liquefy the anchoring material. Such rotary motion preferably has a speed in the range of 10,000 to 100,000 rpm. Another method of generating heat energy for the desired liquefaction involves combining electromagnetic radiation with one of the parts of the implantation device and designing one part of the device so that it is lower to absorb electromagnetic radiation, such absorption preferably taking place in the anchor material to be liquefied or in its liquefaction immediate vicinity. Preferably, electromagnetic radiation in the visible or infrared range is used, with the appropriate laser being the preferred radiation source. Electric heating of one of the device parts is also possible.
[0024] Although the principles of the invention are primarily described in relation to a spinal stabilization device with an interbody support and attachment device, it is assumed that the intervertebral support is dimensionally stable, the approaches of the first, second and third aspects as well as preferred features and examples designs can also be used in other configurations.
[0025] A group of such alternative configurations are configurations with an inter-process spacer. Such an intergrowth spacer is inserted between the spinous processes. Inter-process spacers are known in the art. The concept of the second group of alternative configurations proposes to use fastening technology with one or more fixation devices to the spine, especially the spinous processes.
[0026] In this group of such alternative configurations, teaching relating to the "intervertebral disc" in the above-discussed and further described embodiments is to be replaced by yet another type of implant, namely the intergrowth spacer, and instead of vertebral bodies, anchorage preferably occurs in the outgrowths squamous.
[0027] In the present text, the expression "thermoplastic material that can be liquefied, e.g. by mechanical vibration" or shortly "liquefiable thermoplastic material" or "liquefiable material", is used to describe a material containing at least one thermoplastic component, which material becomes liquid or liquid when heated, in particular when heated by friction, i.e. is a system on one of the pairs of surfaces (contact faces) in contact with each other and vibrating or rotatably moved relative to each other, with a vibration frequency between 2 kHz and 200 kHz, preferably 20 and 40 kHz, and an amplitude between 1 μm and 100 μιτ, preferably about 10 to 30 μm (or about 20 to 40 μιτ). Such vibrations are e.g. generated by ultrasonic devices e.g. known for dental applications. To ensure that the load-bearing tissue can be formed, the material has a coefficient of elasticity greater than 0.5 GPa, preferably greater than 1 GPa and a plasticization temperature of up to 200 ° C, between 200 ° C and 300 ° C or even greater than 300 ° C. In applications where the anchoring material is provided in a supportive, load-bearing structure, in particular in the tubular element of the type discussed here earlier, the modulus of elasticity (in particular Young's modulus) may also be lower than 0.5 GPa, e.g. 0.08 GPa or more, in particular at least 0.1 GPa, for example between 0.1 GPa and 2 GPa. In applications where the anchoring material is provided in a supporting, load-bearing structure, the anchoring material can optionally be completely liquefied during the anchoring operation (and not only in areas close to the surface) and therefore does not necessarily have to transfer vibrations to the shore. An example of an anchor material suitable for such applications are thermoplastic elastomers. A particular example is thermoplastic polyurethane elastomers for example pellethane® from Dow Chemicals.
[0028] Depending on the application, the liquefiable thermoplastic material may or may not be resorbable. Suitable resorbable polymers are e.g. based on lactic acid and / or glycolic acid (PLA, PLLA, PGA, PLGA etc.) or polyhydroxyalkanoates (PHA), polycaprolactones (PCL), polysaccharides, polydioxanones (PD), polyanhydrides, polypeptides or corresponding copolymers or mixed materials or composite materials containing the said polymers as components are suitable as resorbable fluidizable materials. Thermoplastic plastics such as, for example, polyolefins, polyacrylates, polymethacrylates, polycarbonates, polyamides, polyesters, polyurethanes, polysulfones, polyarylketone ketones, polyimides, polyphenylene sulfides or liquid crystal polymers (LCPS), polyacetals, halogenated polymers, halogenated polymers, in particular polyhalides , polysulfones, polyethers, polypropylenes (for example) or suitable copolymers or mixed polymers or composite materials containing said polymers as components are suitable as non-resorbable polymers.
[0029] Specific embodiments of the degradable materials are polyactides such as LR706 PLDLLA 70/30, R208 PLDLA 50/50, L210S and PLLA 100% L, all Bohringer companies. A list of such suitable degradable polymeric materials can also be found in Erich Wintermantel and Suk-Woo Haa, "Medizinaltechnik mit biokompatiblen Materialien und Verfahren", 3. edition, Springer, Berlin 2002 (below referred to as "Wintermantel"), page 200; for information on PGA and PLA, see pages 202 ff., for PCL page 207, for PHB / PHV copolymers page 206; on PDS polydioxanone page 209. A discussion of further bioresorbable materials can be found, for example, in CA Bailey et al., J Hand Surg [Br] 2006 April; 31 (2): 208-12.
[0030] Specific embodiments of non-degradable materials: polyether ketone (PEEK Optima, Grade 450 and 150, Invibio Ltd), polyetherimide, polyamide 12, polyamide 11, polyamide 6, polyamide 66, polycarbonate, poly (methyl methacrylate), polyoxymethylene. An overview table of polymers and applications is specified in Wintermantel, page 150; specific examples can be found in Wintermantel page 161 ff. (PE, Hostalen Gur 812, Hochst AG) pages 164 ff. (PET) 169 ff. (PA, namely PA 6 and PA 66), 171 ff. (PTFE), 173 ff. (PMMA), 180 (PUR, see table), 186 ff. (PEEK), 189 ff. (PSU), 191 ff. (POM - polyacetal, trade names Delrin, Tenac, were also used in prostheses by Protec).
[0031] Examples of suitable thermoplastic materials include poly (lactic acids) such as any of the products LR708 (amorphous Poly-L-DL lactide 70/30), L209 or L210S from Bohringer Ingelheim or polycarbonates.
[0032] Liquefiable material with thermoplastic properties may contain foreign phases or compounds for other purposes. In particular, liquefiable material can be reinforced by mixed fillers, e.g. powder fillers, which may have therapeutic or other desirable effects. The thermoplastic material may also contain ingredients that swell or dissolve (form pores) in place (e.g. polyesters, polysaccharides, hydrogels, sodium phosphates or compounds to be released on site and cause therapeutic effects, e.g., promoting healing and regeneration (e.g., growth factors, antibiotics, inflammatory inhibitors or buffers, such as sodium phosphate or calcium carbonate effects of acid degradation). If the thermoplastic material is resorbable, the release of such compounds is delayed.
[0033] If the liquefiable material is to be liquefied not by means of vibrational energy but by means of electromagnetic radiation, it may locally contain compounds (in the form of particles or molecular) that are capable of absorbing such radiation in a specific frequency range (in particularly in the visible frequency range or in the infrared range), e.g. calcium phosphates, calcium carbonates, sodium phosphates, titanium oxide, mica, saturated fatty acids, polysaccharides, glucose or mixtures thereof.
[0034] The fillers used may contain degradable bone growth promoting fillers for use in degradable polymers, including:
β-calcium phosphate (TCP), hydroxyapatite (HA, crystallinity <90%) or mixtures of TCP, HA, DHCP, bioactive glasses (Bioglasses) (see Wintermantel). Osseointegration-stimulating fillers, which are only partially or almost non-degradable, for non-degradable polymers include: bioactive glasses, hydroxyapatite (HA,> 90% crystallinity), HAPEXR, see SM Rea et al., J Mater Sci Mater Med. September 2004; 15 (9): 997-1005; for hydroxyapatite, also see L. Fang and wps., Biomaterials July 2006; 27 (20): 3701-7, M. Huang et al., J Mater Sci Mater Med. July 2003; 14 (7): 655-60, and W. Bonfield and E. Tanner, Materials World January 1997; 5 No. 1: 18-20. Examples of bioactive fillers and their discussion can be found, for example, in X. Huang and X. Miao, J Biomater App. April 2007; 21 (4): 351-74), JA Juhasz et al. Biomaterials, March 2004; 25 (6): 949-55. Particulate fillers include: coarse types: 5-20 μm (content, preferably 10-25% by volume), submicron (nanofillers, such as from precipitation, preferably with a plate ratio> 10, 10-50 nm, content 0.5 to 5% v).
[0035] More generally, liquefaction in these embodiments is obtained by using materials with thermoplastic properties having a melting point up to about 350 ° C. If the liquefaction limit or one of the many liquefaction limits is between the part of the device containing the liquefiable material and the associated element, the elastic modulus of the liquefiable material should be at least 0.5 GPa, so that the liquefiable material is able to transfer oscillations with so little attenuation that internal liquefaction, and therefore no destabilization of the said part of the device occurs, i.e. liquefaction only occurs where liquefiable material is on the verge of liquefaction. As long as the oscillation tool limit serves as the liquefaction interface, the material can, in principle, also have a lower modulus of elasticity. However, in some applications, due to the load transfer function, the material also has, in this situation, an advantageous modulus of elasticity of at least 0.5 GPa. As discussed above, the modulus of elasticity may be less than 0.5 GPa in applications where the anchoring material is provided with an additional supportive, load-bearing structure, such as a tubular structure.
[0036] Teaching of the present text also relates to methods of implanting a spinal stabilization device and sets of parts that include a spinal stabilization device, and further includes implantation tools described in more detail with reference to some of the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS [0037] Below, embodiments of the invention are described with reference to the figures. The figures are completely schematic and not to scale. In the figures, the same reference numbers designate the same or analogous elements. The drawings show:
- Figures 1-3 an embodiment of the invention;
- Fig. 4 the principle of guiding the element from the anchoring material by means of e.g. a sonotrode;
- Fig. 5 - an alternative embodiment of the anchoring device for the device according to the third aspect of the invention;
DESCRIPTION OF PREFERRED EMBODIMENTS [0038] Figs. 1-3 show embodiments of the invention. The embodiments in Figs. 1-3 include anchoring devices, e.g. of the type described in WO 2008/034 276. In addition to the embodiments described in WO 2008/034 276, however, the anchoring devices of this aspect of the invention include, first and second fastening parts each approximately pin-shaped in the embodiment shown, and two fastening parts connected by a bridge portion that projects on the distal side less than fastening parts.
[0039] Teaching that relates to devices such as those shown in Figs. 1-3 can be used, for example, to attach the respective upper and lower parts of the plate (retainers) of the intervertebral disc prosthesis.
[0040] Fig. 1 shows an embodiment of a spine stabilization device according to this aspect inserted into the human spine. Fig. 1 shows the upper vertebra 1 and the lower vertebra 2 between which the intervertebral disc has been at least partially removed. The device according to the embodiment described here also comprises an interbody spacer 3 serving as an element maintaining the distance between the vertebral bodies of the upper vertebra and the lower vertebra. The interbody spacer after surgical insertion between the vertebral bodies is held in place by a number of anchor devices 121.
[0041] Fig. 2 shows the interbody spacer 3. The interbody spacer can again be made of any suitable PEEK containing material potentially coated with hydroxyapatite (HA). Alternatively, it may be made of another biocompatible material suitable for intervertebral discs, such as plastic, ceramics or titanium, also potentially coated.
[0042] The interbody spacer 3 comprises an upper surface 11 and an opposite lower surface intended to be in contact with the lower end plate of the upper vertebral body and the upper end plate of the lower vertebral body, respectively. The interbody spacer further comprises a longitudinal (relative to the axis of the spine) through hole 12, allowing bone growth between the upper and lower vertebral bodies, and optionally filled when surgically inserted, through bone graft and / or bone growth activating material.
[0043] In the configuration shown, the interbody spacer comprises one through hole that is located centrally to the sagittal plane. However, other numbers and arrangements of longitudinal holes are possible. For example, it is also possible to have two or more, possibly smaller, central through holes, or one or more holes in the lateral position or no hole at all, etc.
[0044] Furthermore, the interbody spacer 3 may be shaped to suit the surgeon's needs and include retaining structures and / or macroscopic and microscopic structures for bone growth, such as holes 13 perpendicular to the longitudinal axis shown in the figure, channels. e.t.c.
[0045] The intervertebral disc has four channel recesses 123 which are open to both the abdominal side and the upper or lower side. At least in the vicinity of the cavities, the intervertebral spacer further comprises an open porous structure, preferably with macroscopic pores, which can be penetrated internally by the liquid anchor material. This creates a macro type belt connection. Instead of an open porous structure, there may also be a structure with a single cavity (or several cavities) with an undercut, so that the resulting macro joint is a riveted joint.
[0046] The anchoring device as shown in Fig. 3 consists of a thermoplastic material that can be liquefied, for example, by the combined action of mechanical vibration and pressure, such as polylactic acid (PLA). It includes an upper and lower fastening portion 127, as well as a bridge portion 128 between the anchoring parts. The fastening portions 127 are pin-shaped with energy directing elements 129. Each attachment portion has a tip 125 extending to the distal side, preferably further than the bridge portion.
[0047] During the anchoring process, one of the fastening parts 127 is inserted into the recess 123 of the intervertebral disc 3, while the other fastening part is inserted into the pre-drilled recess in the vertebral body adjacent to the recess 123. Thus, both the recess 123 in the intervertebral disc 3 and the bone tissue cavity is configured to have a diameter that is smaller than the outer diameter of the respective attachment portion 127. When inserted into the space containing the cavities 123 in the intervertebral disc and in the vertebral body, the thermoplastic material of the fastening parts due to the effect of, for example, mechanical vibrations connected in the anchoring device, begins to be liquid and penetrates the open porous structure, respectively of the intervertebral spacer and vertebral tissue, respectively. After anchoring, the sternum connects due to the resulting positive shape connection of the fastening parts with the open porous structure and bone tissue, the intervertebral spacer and the vertebral body to each other. If the anchoring devices 121 are selected from resorbable material after resorption, bone tissue will grow into the cavities 123 in the intervertebral spacer and into the open porous structure 124.
[0048] As mentioned above for other embodiments of the spine stabilization device according to the invention, it is possible for the embodiment as shown in Fig. 25 up to 27 also liquefied the anchoring material composed of fastening parts 127 by combining electromagnetic radiation preferably with a visible or infrared frequency range to the fastening parts 127 and absorbing radiation in the vicinity of the surface of the fastening parts that are in contact with the bone tissue of the spine or with the intervertebral spacer between them , producing the heat energy needed for the desired liquefaction.
[0049] Fig. 5 shows an embodiment of a hybrid type anchor device, i.e. which includes in addition to parts of a liquefiable material, also parts of a non-liquefiable material. More specifically, the anchoring device 121 includes a metal core 161, constituting a bridge portion 128 and a core of two attachment portions 127 and, for each attachment portion, an outer portion 162 consisting of liquefiable material.
[0050] Fig. 4 shows an element 31 of anchoring material for embodiments not according to the claimed invention, mounted on a sonotrode 67 comprising a sonotrode tip 151. The sonotrode tip is equipped with retaining structures (such as a thread) for a fixed connection to the element made of anchoring material; it is also possible that the anchoring material element is held only by friction. In embodiments where the anchoring structure comprises a longitudinal recess accessible from the front, the length of the sonotrode tip 151 is preferably smaller than the length of the longitudinal recess, so that the proximal end of the sonotrode tip also defines the resistance degree for the anchoring operation.
[0051] The sonotrode tip 151 exerts a guide effect on the anchor material element, and this turns out to have a beneficial effect in many configurations.
[0052] For embodiments, an analog guiding device with a double sonotrode (not shown) can be used.
[0053] Various other embodiments can be envisioned without departing from the scope and spirit of the invention. For example, although the figures for illustrative purposes generally depict the lumbar vertebra, the invention may also be used for all other vertebrae, in particular including the cervical and thoracic vertebrae.
[0054] The anchoring operation, in embodiments where liquefaction of the polymeric material occurs, can be carried out manually or at least partly automatically. In the last case of experts, reference is made to the description of document US2009 018471 or WO 2011/054123.
[0055] Although all the figures that show the device for stabilizing the spine in the inserted state of the spine relate to the implant for vertebral fusion replacing the intervertebral disc, teaching of all the figures can also be used in situations where the entire vertebra and the adjacent intervertebral disc are replaced. In addition, embodiments of the invention that do not require a dimensionally rigid interbody can be used for intervertebral disc prostheses.
SpineWelding AG, Switzerland
Proxy:
EP 2 992 860 B1 Z-15996/17
36 members in 12 offices
Priority claims10
| Document | Office | Kind | Date |
|---|---|---|---|
| 15524109 | United States of America | P | |
| 24207109 | United States of America | P | |
| 30260810 | United States of America | P | |
| 10704886 | European Patent Office (EPO) | A | |
| 15187222 | European Patent Office (EPO) | A | |
| EP20100704886 | – | – | – |
| EP20150187222 | – | – | – |
| US20090155241P | – | – | – |
| US20090242071P | – | – | – |
| US20100302608P | – | – | – |
Members36
| Document | Office | Kind | |
|---|---|---|---|
| CA2753439A1 | Canada | A1 | |
| WO2010096942A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US2010274358A1 | United States of America | A1 | |
| EP2400931A1 | European Patent Office (EPO) | A1 | |
| CN102438556A | China | A | |
| JP2012518499A | Japan | A | |
| RU2011138719A | Russian Federation | A | |
| RU2535775C2 | Russian Federation | C2 | |
| CN102438556B | China | B | |
| CN104887360A | China | A | |
| JP2015163233A | Japan | A | |
| JP5792635B2 | Japan | B2 | |
| EP2400931B1 | European Patent Office (EPO) | B1 | |
| US9220609B2 | United States of America | B2 | |
| ES2560206T3 | Spain | T3 | |
| EP2992860A1 | European Patent Office (EPO) | A1 | |
| US2016074171A1 | United States of America | A1 | |
| PL2400931T3 | Poland | T3 | |
| HUE026695T2 | Hungary | T2 | |
| EP2992860B1 | European Patent Office (EPO) | B1 | |
| HK1221893A | Hong Kong, China | A | |
| HK1221893A1 | Hong Kong, China | A1 | |
| CA2753439C | Canada | C | |
| EP3207901A1 | European Patent Office (EPO) | A1 | |
| ES2634714T3 | Spain | T3 | |
| PL2992860T3This record | Poland | T3 | |
| CN104887360B | China | B | |
| JP6310416B2 | Japan | B2 | |
| JP2018153633A | Japan | A | |
| US10195045B2 | United States of America | B2 | |
| US2019133777A1 | United States of America | A1 | |
| JP6621492B2 | Japan | B2 | |
| BRPI1009207A2 | Brazil | A2 | |
| BRPI1009207B1 | Brazil | B1 | |
| US11259934B2 | United States of America | B2 | |
| EP3207901B1 | European Patent Office (EPO) | B1 |
Numbers
- Publication, DOCDB
- 2992860
- Publication, EPODOC
- PL2992860T
- Application
- 20150187222
- Application, DOCDB
- 15187222
- Application, EPODOC
- PL20150187222T
Titles2
- English
- SPINE STABILIZATION DEVICE
- Polish
- Urządzenie do stabilizacji kręgosłupa
Classification
- CPC, 25
- A61F2/442
- A61B17/7059
- A61B17/7098
- A61B17/864
- A61B17/8822
- A61B17/8836
- A61F2/447
- A61F2/4601
- A61F2002/2835
- A61F2002/30387
- A61F2002/30401
- A61F2002/30578
- A61F2002/30593
- A61F2002/30594
- A61F2002/30736
- A61F2002/30785
- A61F2002/30904
- A61F2002/4627
- A61F2002/4628
- A61F2002/4629
- A61F2220/0008
- A61F2220/0025
- A61F2310/00023
- A61F2310/00179
- A61F2310/00796
- IPC, 7
- A61B17 70
- A61B17 86
- A61B17 88
- A61F2 28
- A61F2 30
- A61F2 44
- A61F2 46